MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM QUICK SET MMT-397T; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-397T

Device Problems Excess Flow or Over-Infusion (1311); Appropriate Term/Code Not Available (3191)

Patient Problem Death (1802)

Event Date 09/04/2017

Event Type  Death  

Manufacturer Narrative

Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

Event Description

It was reported that the customer passed away at home.The cause of death was still unknown.The cause of death is still under investigation.The caller stated that the customer had no illnesses that may have led to the customer's passing.The customer¿s blood glucose was unknown at the time of death.The customer was wearing the insulin pump at the time of death.The customer was not using sensors.The caller wanted information on how to stop supply shipment and what to do with the unused infusion sets.It was reported via legal documents that the customer had an apparent insulin overdose that resulted in their passing.The caller agreed to return the insulin pump for analysis.

• Brand Name: PARADIGM QUICK SET MMT-397T
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire st.; northridge, CA 91325-1219 ; 8185464805
• MDR Report Key: 8524247
• MDR Text Key: 142259621
• Report Number: 2032227-2019-03220
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-397T
• Device Catalogue Number: MMT-397T
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/26/2019
• Initial Date FDA Received: 04/17/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 64 YR
• Patient Weight: 240